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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2009-012810-29 |
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| Name | Class |
|---|---|
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
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The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sévoflurane | Active Comparator | hypnotic use in standard general anesthesia |
|
| LENOXe™ (xénon 100 % v/v) | Experimental | Safety of use in terms of hemodynamic stability to the LENOXe™ (xénon 100 % v/v) within the framework of the carotid surgery on the old person |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xenon | Drug | Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used | Pre-op, every min from 1-90 min during maintenance phase |
| Measure | Description | Time Frame |
|---|---|---|
| cardiovascular, general, hepatic and renal tolerance to xenon. Quality and time of awakening, recovery index (IR);Post-op pain (EVA)and consumption of analgesic; Inflammatory Syndrome (cytokine profile); Subjective comfort of the patient | During the whole anesthetic procedure and the postoperating time until 24 hours after discharge from the recovery room / intensive care unit and return to the ward |
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Inclusion Criteria:
Exclusion Criteria:
Related to the patients:
Related to the surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre CORIAT, Pr | Groupe Hospitalier Pitie-Salpetriere | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pitié-Salpêtrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Hemodynamic stability of xenon during general anaesthesia for carotid endariectomia in old patientsJune 2011European Journal of Anaesthesiology 28:45DOI:10.1097/00003643-201106001-00138 Yannick Le Manach, G. DouffléJ. P. Goarin, Irene Santos Cristina |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| sévoflurane | Drug | Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery |
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